postoperative nausea and vomiting
Conditions
Interventions
Group amisulpride+dexamethasone:2ml amisulpride injection and 5mg dexamethasone were given after induction.
Group placebo+dexamethasone:2ml 0.9% sodium chloride injection and 5mg dexamethasone were given after induction.
Sponsors
Nanjing Jiangning Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) 18= age =75 years old, gender is not limited; (2) Body mass index (BMI) between 18.0 and 30.0kg / ? (including the critical value); (3) The subject is graded I-III according to the American College of Anesthesiologists (ASA) classification criteria; (4) Hospitalized subjects who plan to undergo abdominal surgery (including gynecological surgery) under general anesthesia (propofol/cyclopofol anesthesia induction is allowed, propofol/cyclopofol anesthesia maintenance is prohibited) and are expected to maintain inhalation anesthesia for at least 1 hour; (5) The researchers used Apfel to simplify the risk score to determine the subjects at high risk of postoperative nausea and vomiting (PONV); (6) The subject can understand the procedures and methods of the clinical trial, and after full informed consent, voluntarily participate in the informed consent signed by the subject or legal guardian; (7) Be able to read, understand and complete the self-assessment scale of nausea degree and the evaluation form related to efficacy.
Exclusion criteria
Exclusion criteria: (1) Subjects who are known to be scheduled to receive local anesthesia only, such as surface anesthesia, local infiltration anesthesia, regional block, nerve block, intraspinal anesthesia (intrathecal or epidural block); (2) Allergic to or have a history of special reactions to amisulpride injection or any excipient or any component of the drug used in this test; (3) Patients who have a history of or are currently suffering from any of the following clinically serious diseases that are determined by the investigator to affect the study: ? Respiratory diseases: subjects with severe respiratory diseases who need to be transferred to ICU for respiratory support after surgery; ?Central nervous system diseases: subjects with epilepsy, Parkinson's disease, or other central nervous system diseases that cause nausea and vomiting, such as craniocerebral injury, intracranial space occupation, intracranial aneurysm, etc.; ?Cardiovascular disease: Severe cardiac insufficiency (class III-IV according to the New York Heart Association [NYHA]), unstable angina, acute myocardial infarction, refractory hypertension (poor control of hypertension treated with three or more antihypertensive drugs) in the 6 months prior to screening: Systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg) and other heart disease deemed clinically significant by investigators; ?Digestive disorders: Subjects with intestinal obstruction or other digestive disorders that cause nausea and vomiting; ?Subjects with clinically significant arrhythmias: such as prolonged QTcF interval (male =450 ms, female =460 ms), severe bradycardia (heart rate =45 beats/min), severe degree II or III atrioventricular block (excluding subjects using pacemakers), atrial fibrillation, etc.; ? Subjects with congenital history of long QT syndrome or family history of QT syndrome; ?Have a clear diagnosis of vestibular disease (including but not limited to: external vestibular syndrome, central vestibular syndrome, etc.); ?Subjects with a history of significant, chronic dizziness; ? Subjects with prolactin-dependent tumors (such as pituitary prolactinoma or breast cancer), or pheochromocytoma. (4) The laboratory test results during the screening period meet the following criteria: ? Hemoglobin Hb=90g/L; ? Platelet count PLT=50109/L; ? Clinically significant hypokalemia: blood potassium value 1.5 times the upper limit of normal value; ? Kidney function: creatinine > 1.2 times the upper limit of normal; ? Prothrombin time (PT) > upper normal value +3s, or partially activated thrombin time (APTT) > upper normal value +10s. (5) Subjects with a history of substance abuse or substance abuse within the 6 months prior to randomization(including alcohol, opioids, sedative anti-anxiety drugs, antibiotics, cisapride, mosapride and other gastric motion-boosting agents); (6) Subjects who had received chemotherapy or had malignant tumors within 4 weeks prior to screening; (7) Participants who had received or were receiving the active ingredient of amsulpride injection within 2 weeks prior to randomization; (8) Subjects who were receiving levodopa or other targeted drugs (domperidone, levosulpiride, metoclopramide, chlorpromazine, clozapine) within 2 weeks prior to randomization; (9) Participants who had received drugs that induced tip torsion ventri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response (CR) rate after surgery (defined as no episodes of vomiting (vomiting or retching) within 24 hours immediately after surgery, and no remedial medication was used).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with nausea after surgery;Proportion of patients with significant nausea (score > 4) postoperatively;Proportion of patients with vomiting after surgery;Proportion of patients treated with rescue drugs after surgery; | — |
Countries
China
Contacts
Public ContactYu Wanyou
Nanjing Jiangning Hospital
Outcome results
None listed